質(zhì)量安全是血液制品的最關(guān)鍵的內(nèi)容，亦是最基本的要求。藥品生產(chǎn)六大系統(tǒng)實(shí)際上已涵蓋了影響藥品質(zhì)量的各要素。對(duì)國內(nèi)外藥品監(jiān)管和檢查機(jī)構(gòu)針對(duì)全球血液制品生產(chǎn)企業(yè)檢查缺陷的收集、梳理與分析，結(jié)合血液制品生產(chǎn)質(zhì)量管理的特點(diǎn)，對(duì)血液制品生產(chǎn)質(zhì)量管理中質(zhì)量管理系統(tǒng)、設(shè)施設(shè)備系統(tǒng)、物料系統(tǒng)、生產(chǎn)系統(tǒng)、包裝和標(biāo)簽系統(tǒng)、實(shí)驗(yàn)室控制系統(tǒng)的管理要點(diǎn)和常見問題進(jìn)行分析，為血液制品監(jiān)督檢查、企業(yè)持續(xù)提升質(zhì)量管理水平提供建議和參考。

The quality and safety represent the most crucial aspect and fundamental requirement of blood products. The six major systems of drug production actually covered various elements that affected drug quality. This article collects, sorts out, and analyzes the inspection defects of global blood product production enterprises by domestic and foreign drug regulatory and inspection agencies. Combining with the characteristics of blood product production quality management, it analyzes the management points and common problems of quality management system, facility and equipment system, material system, production system, packaging and labeling system, and laboratory control system in blood product production quality management. The aim is to provide suggestions and references for blood product supervision and inspection, as well as for enterprises to continuously enhance their quality management standards.

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